Dental Caries on Pit and Fissure SurfaceNCT03077035
Using ICDAS II and KaVo DIAGNOdent Pen Detecting Tooth Pit and Fissure Level Incipent Caries Progression
A study testing glass ionomer sealants and resin-based sealant in people with Dental Caries on Pit and Fissure Surface, run by Sheng-Chao Wang at 1 site in China.
Trial summary
The study was to monitor effectiveness of glass ionomer sealant and resin-based sealant in ICDAS, and to evaluat the correlation between ICDAS and DIAGNOdent over 24 months. Over 200 8-year-old children with at least 2 permanent molar with the International Caries Detection and Assessment System (ICDAS) scores 0-4… Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries on Pit and Fissure Surface
- What is being tested?
- glass ionomer sealants and resin-based sealant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2015to 1 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects provided written informed consent;
- They were 7 to 9 years old;
- They have at least 2 permanent molar with the International Caries Detection and Assessment System (ICDAS) scores 0-4;
- They were generally heallthy
Who cannot join
- They were allergic to the constituents in pit and fissure sealants
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
School of Stomatology The Fourth Military Medical University
Xi'an, Shaanxi, 710032
Shengchao Wang, PHD, 86-29-84776159, wangshengchao@fmmu.edu.cn
About this study
The study was to monitor effectiveness of glass ionomer sealant and resin-based sealant in ICDAS, and to evaluat the correlation between ICDAS and DIAGNOdent over 24 months. Over 200 8-year-old children with at least 2 permanent molar with the International Caries Detection and Assessment System (ICDAS) scores 0-4 were placed glass ionomer sealant and resin-based sealant split-mouthed randomly, and examined with ICDAS and DIAGNOdent before sealents placement and 6, 12 and 24 months after.
- Conditions
- Dental Caries on Pit and Fissure Surface
- Being tested
- glass ionomer sealants, resin-based sealant
- Keywords
- ICDAS, DIAGNOdent, glass ionomer sealant, resin-based sealant, pit and fissure sealants, effectiveness of preventing caries
- Medical subject headings
- Van der Woude syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glass ionomer sealantsOther
resin-based sealantOther
| Study group | Role | What they receive |
|---|---|---|
| glass ionomer sealant | Experimental | Not described Receives: Other: glass ionomer sealants |
| resin-based sealant | Active comparator | Not described Receives: Other: resin-based sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Decayed Surfaces (DS) of Different Fissure Sealants
Count of DS in different ICDAS cut-off( including D1-6S, D1-2S, D3-6S, D4-6S and D5-6S) in the baseline and 6-month, 12-month and 24-month follow-up.
Measured: Baseline, 6 months, 12 months and 24 months
Change in Repaired Sealants by the baseline ICDAS
Evaluation the numbers of tooth surface in which the fissure sealants were in the status partially retained or completely lost, and ICDAS score were increasing from the baseline to the 3 follow-ups.
Measured: 6 months, 12 months and 24 months
Change in DIAGNOdent Score
The peak value of DIAGNOdent was recorded after repeating it 3 times in the baseline and 3 follow-ups
Measured: Baseline, 6 months, 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start1 Oct 2015
- Primary completion1 Oct 2017 (estimated)
- Study completion1 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries on Pit and Fissure SurfaceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheng-Chao Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sheng-Chao Wang, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077035
- Sponsor's protocol ID
- GJ-02
- Status last verified
- Mar 2017
- First submitted
- 23 Feb 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using ICDAS II and KaVo DIAGNOdent Pen Detecting Tooth Pit and Fissure Level Incipent Caries Progression
- ClinicalTrials.gov ID
- NCT03077035
- Acronym / sponsor ID
- GJ-02
- Conditions
- Dental Caries on Pit and Fissure Surface
- Keywords
- ICDAS, DIAGNOdent, glass ionomer sealant, resin-based sealant, pit and fissure sealants, effectiveness of preventing caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sheng-Chao WangUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Oct 2017 (estimated)
- Study completion
- 1 Nov 2017 (estimated)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was to monitor effectiveness of glass ionomer sealant and resin-based sealant in ICDAS, and to evaluat the correlation between ICDAS and DIAGNOdent over 24 months. Over 200 8-year-old children with at least 2 permanent molar with the International Caries Detection and Assessment System (ICDAS) scores 0-4 were placed glass ionomer sealant and resin-based sealant split-mouthed randomly, and examined with ICDAS and DIAGNOdent before sealents placement and 6, 12 and 24 months after.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glass ionomer sealant | Experimental | Other: glass ionomer sealants |
| resin-based sealant | Active comparator | Other: resin-based sealant |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subjects provided written informed consent;
- They were 7 to 9 years old;
- They have at least 2 permanent molar with the International Caries Detection and Assessment System (ICDAS) scores 0-4;
- They were generally heallthy
Key exclusion criteria (1 listed)
- They were allergic to the constituents in pit and fissure sealants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glass ionomer sealants | Other | glass ionomer sealant |
| resin-based sealant | Other | resin-based sealant |
Primary outcome
Change in Decayed Surfaces (DS) of Different Fissure Sealants
Time frame: Baseline, 6 months, 12 months and 24 months
Count of DS in different ICDAS cut-off( including D1-6S, D1-2S, D3-6S, D4-6S and D5-6S) in the baseline and 6-month, 12-month and 24-month follow-up.
Change in Repaired Sealants by the baseline ICDAS
Time frame: 6 months, 12 months and 24 months
Evaluation the numbers of tooth surface in which the fissure sealants were in the status partially retained or completely lost, and ICDAS score were increasing from the baseline to the 3 follow-ups.
Change in DIAGNOdent Score
Time frame: Baseline, 6 months, 12 months and 24 months
The peak value of DIAGNOdent was recorded after repeating it 3 times in the baseline and 3 follow-ups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glass ionomer sealants and resin-based sealant in people with Dental Caries on Pit and Fissure Surface, run by Sheng-Chao Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Guo, MM (86-29-84776479, lucyjing@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Decayed Surfaces (DS) of Different Fissure Sealants (time frame: Baseline, 6 months, 12 months and 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.